Internet-based Intervention for Skin Self-Examination in Participants With Increased Risk for Melanoma
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Skin Cancer, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 12/2/2018 |
| Start Date: | December 3, 2018 |
| End Date: | December 3, 2020 |
An Online Intervention for Skin Self-Checks Among Individuals at Increased Risk for Melanoma
This trial studies an internet-based intervention for skin self-examination (SSE) in
participants at increased risk for melanoma. Early detection of suspicious growths on the
skin can be done by performing regular SSE checks. Using an internet-based intervention, such
as mySmartCheck, may help to promote regular, thorough checks on the skin in individuals at
increased risk for melanoma.
participants at increased risk for melanoma. Early detection of suspicious growths on the
skin can be done by performing regular SSE checks. Using an internet-based intervention, such
as mySmartCheck, may help to promote regular, thorough checks on the skin in individuals at
increased risk for melanoma.
PRIMARY OBJECTIVES:
I. To evaluate the impact of mySmartCheck versus ususal care on skin-self-examination (SSE)
behaviors among individuals at increased risk for developing melanoma.
SECONDARY OBJECTIVES:
I. To evaluate the impact of mySmartCheck versus usual care on patients barriers and benefits
to conducting SSE, SSE self-efficacy (confidence), level of worry about developing melanoma,
and number of health care consultations (visits, telephone calls, and emails).
II. To evaluate whether mySmartCheck effects are moderated by the patient's Total Body
Photography (TBP) status.
III. To identify barriers and facilitators to using mySmartCheck.
OUTLINE:
PHASE I: Participants complete a telephone based usability testing of the online program.
Participants complete between 1-5 user testing sessions of the mySmartCheck program (about
45-60 minutes per session) to provide feedback on acceptability, satisfaction, comprehension,
and usability.
PHASE II: Participants are randomized to 1 of 2 groups. Both the intervention and control
group complete a baseline survey as well as a 13 weeks post-baseline survey.
GROUP I: After completing the baseline survey, participants receive access to the
mySmartCheck program, and continue to receive standard of care. Participants are asked to
complete another survey 13 weeks post-baseline.
GROUP II: After completing the baseline survey, participants receive standard of care.
Participants are asked to complete another survey 13 weeks post-baseline.
Study duration is 13 weeks for all participants.
I. To evaluate the impact of mySmartCheck versus ususal care on skin-self-examination (SSE)
behaviors among individuals at increased risk for developing melanoma.
SECONDARY OBJECTIVES:
I. To evaluate the impact of mySmartCheck versus usual care on patients barriers and benefits
to conducting SSE, SSE self-efficacy (confidence), level of worry about developing melanoma,
and number of health care consultations (visits, telephone calls, and emails).
II. To evaluate whether mySmartCheck effects are moderated by the patient's Total Body
Photography (TBP) status.
III. To identify barriers and facilitators to using mySmartCheck.
OUTLINE:
PHASE I: Participants complete a telephone based usability testing of the online program.
Participants complete between 1-5 user testing sessions of the mySmartCheck program (about
45-60 minutes per session) to provide feedback on acceptability, satisfaction, comprehension,
and usability.
PHASE II: Participants are randomized to 1 of 2 groups. Both the intervention and control
group complete a baseline survey as well as a 13 weeks post-baseline survey.
GROUP I: After completing the baseline survey, participants receive access to the
mySmartCheck program, and continue to receive standard of care. Participants are asked to
complete another survey 13 weeks post-baseline.
GROUP II: After completing the baseline survey, participants receive standard of care.
Participants are asked to complete another survey 13 weeks post-baseline.
Study duration is 13 weeks for all participants.
Inclusion Criteria:
- At increased risk for melanoma due to a personal history of treated melanoma without
current evidence of disease, a family history of melanoma in a first-degree relative,
and/or having a high-risk mole phenotype (i.e., >= 50 normal moles or >= 1 abnormal
mole [dysplastic nevus]).
- Access to a computer connected to the Internet.
- Not adherent to SSE recommendations (i.e., did not conduct a thorough SSE during each
of the previous 3 months).
- Able to speak and read English.
- Able to provide informed consent.
We found this trial at
1
site
New Brunswick, New Jersey 08903
Principal Investigator: Elliot J. Coups
Phone: 732-235-8076
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